ClinicalTrials.gov record
Active, not recruiting Phase 2 Interventional

Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation

ClinicalTrials.gov ID: NCT04203316

Public ClinicalTrials.gov record NCT04203316. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:46 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Feasibility Study to Assess the Safety and Pharmacokinetics of Enasidenib in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (R/R-AML) With an Isocitrate Dehydrogenase-2 (IDH2) Mutation

Study identification

NCT ID
NCT04203316
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Children's Oncology Group
Network
Enrollment
1 participant

Conditions and interventions

Interventions

  • Biospecimen Collection Procedure
  • Bone Marrow Aspiration Procedure
  • Bone Marrow Biopsy Procedure
  • Enasidenib Drug
  • Enasidenib Mesylate Drug

Procedure · Drug

Eligibility (public fields only)

Age range
24 Months to 21 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 13, 2023
Primary completion
Sep 29, 2025
Completion
Oct 2, 2026
Last update posted
Jan 8, 2026

2023 – 2026

United States locations

U.S. sites
27
U.S. states
20
U.S. cities
26
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233
Arkansas Children's Hospital Little Rock Arkansas 72202-3591
Children's Hospital Colorado Aurora Colorado 80045
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado 80218
Alfred I duPont Hospital for Children Wilmington Delaware 19803
MedStar Georgetown University Hospital Washington D.C. District of Columbia 20007
Children's National Medical Center Washington D.C. District of Columbia 20010
UF Health Cancer Institute - Gainesville Gainesville Florida 32610
Nicklaus Children's Hospital Miami Florida 33155
Lurie Children's Hospital-Chicago Chicago Illinois 60611
Riley Hospital for Children Indianapolis Indiana 46202
Norton Children's Hospital Louisville Kentucky 40202
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland 21287
C S Mott Children's Hospital Ann Arbor Michigan 48109
Children's Mercy Hospitals and Clinics Kansas City Missouri 64108
Hackensack University Medical Center Hackensack New Jersey 07601
State University of New York Upstate Medical University Syracuse New York 13210
Montefiore Medical Center - Moses Campus The Bronx New York 10467
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224
Saint Jude Children's Research Hospital Memphis Tennessee 38105
Vanderbilt University/Ingram Cancer Center Nashville Tennessee 37232
UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas 75390
Children's Hospital of San Antonio San Antonio Texas 78207
Children's Hospital of The King's Daughters Norfolk Virginia 23507

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04203316, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 8, 2026 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04203316 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →